The subject matter disclosed herein relates to the field of re-usable medical equipment or components and sterilization methods therefore, and more specifically to devices and methods for determining the sterilization status and useful life of these types of re-usable equipment and components.
To assist in in the performance of different medical procedures a number of replaceable equipment and components for different medical devices for use in these procedures have been developed. These components can be used in a procedure for a particular patient and then sterilized for use in another procedure on the, same or a different patient. After the component has been put through a number of sterilization cycles and thus reached the end of its useful life, then the component can be disposed of and replaced with an identical component, increasing the ease of performance of the procedures utilizing the component.
One of the significant issues with re-usable components of this type concerns the sterilization of the components between subsequent uses. In particular, ensuring that the components/equipment moving from patient to patient have gone through appropriate sterilization/decontamination is a significant issue for the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in regard to infection controls Healthcare-associated infections (HAI) are most commonly caused by viral, bacterial, and fungal pathogens. Patient-related risk factors for invasion of colonizing pathogen include severity of illness, underlying immunocompromised state and/or the length of in-patient stay. Most patients who have healthcare-associated infections caused by bacterial and fungal pathogens have a predisposition to infection caused by invasive supportive measures, equipment and components, e.g., such as endotracheal intubation, placement of intravascular lines, urinary catheters, etc.
To illustrate the importance of proper sterilization/decontamination of these types of components/equipment, in the United States healthcare-associated infections (HAI) are estimated to occur in 5% of all hospitalizations. Internationally, both developed and resource-poor countries are fitted with the burden of healthcare-associated infections. In a World Health Organization (WHO) cooperative study, about 8.7% of hospitalized patients had developed nosocomial infections. A 6-year study from 2002-2007 involving intensive care units (ICUs) in Latin America, Asia, Africa, and Europe, using the Center for Disease Controls definitions, revealed higher rates of Ventilator Associated Pneumonias (VAP) than those of comparable United States ICUs. In March 2009, the CDC released a report, estimating overall annual direct medical costs of healthcare-associated infections that ranged from $28-45 billion. Among pediatric patients, children younger than 1 year, babies with extremely low birth weight (1000 g) and children in either the PICU or NICE have higher rates of healthcare-associated infections. For example, of the hospital acquired infections recently studied among pediatric intensive care units. 95% of all pneumonia cases were in patients undergoing mechanical ventilation.
Most medical devices/components are typically reprocessed/sterilized on a periodic basis that can vary depending on the infection control policy for the particular institution. In addition, the cleaning and autoclave schedule can vary by institution, region or availability of autoclave facilities. However, infections from inadequately reprocessed/sterilized devices are not often recognized and the number of HAIs that can be attributed to inadequate device reprocessing is unknown because it is not, often investigated as a cause of HAI.
To attempt to address the issue certain prior art devices have been developed that assist in the sterilization of these components to limit the occurrences of HAIs. In one prior art example, disclosed in U.S. Pat. No. 8,600,374 entitled Sterilizable Wireless Tracking And Communication Device And Method For Manufacturing, which is expressly incorporated herein by reference for all purposes, a wireless communication device is provided that includes a circuit board within a water-tight enclosure. The device includes sensors capable of sensing and monitoring the environment in which the device is positioned, such as a motion sensor, a temperature sensor and/or a pressure sensor. When these sensors detect a change in the environment of the device, such as when the device is positioned within an autoclave, that information is wirelessly transmitted to a network. The sensors, also send a signal to the network when the change to the environment of the device is removed, such as when the device is removed from within the autoclave. The information transmitted by the device to the network can include in addition to the signal representative of the chance in the environment of the device, the time the changes occurred, the value of the changes, and the position of the device. This information can then be compared with standards for the sterilization of the device and any medical equipment or components associated with the device, in order to determine whether the equipment/components have been sufficiently sterilized.
However, while providing useful information about the level of sterilization applied to the equipment or component in a particular sterilization cycle, the prior art concerns only the sterilization of the equipment or component and does not address other issues concerning the ongoing utility of the particular component, which must be assessed visually or in some other non-standardized manner.
Hence it is desirable to provide a device and method for qualification of valid autoclave cycle, but that also integrates the data obtained by the device into the system or network for further use/processing by the network to provide additional information on the particular component, such as predictive end-of-life calculations, intelligent service metrics, and institutional infection control compliance, among others.